IB Diffusion 2.0
IB Diffusion 2.0 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Imaging Biometrics, LLC, cleared under FDA 510(k) K123302 on 11 Jan 2013 and listed in FDA GUDID since 20 Nov 2017 (UDI-DI B319IBDIFFUSION20), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB319IBDIFFUSION20 | Date20 Nov 2017 | StatusListed |
| United States | FDA 510(k) | NumberK123302 | Date11 Jan 2013 | StatusActive |
Official records
- FDA 510(k) database K123302
Across registries
- FDA 510(k) K123302 decided 11 Jan 2013 Active
- FDA GUDID UDI-DI B319IBDIFFUSION20 listed 20 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K123302
- Listed FDA GUDID B319IBDIFFUSION20
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- IB Diffusion
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 2.0
- Primary DI / UDI-DI
- B319IBDIFFUSION20
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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